The Recall Desk

Hazard

Screening Test recalls

2 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2025-12-24

Of the 2 screening test recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all screening test recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–2 of 2

  • HighFDA (Devices)·Z-0940-2026·2025-12-24

    Newborn hearing screening probes recalled over the potential for false passes

    PATH is recalling MADSEN AccuScreen probes because distortions after a speaker replacement can mimic true DPOAE responses and may result in a false PASS outcome.

    Product
    MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0725-2026·2025-12-10

    Fecal immunochemical tests recalled over the potential for false negative results

    Enterix is recalling 201,426 InSure ONE Fecal Immunochemical Test kits after the test failed sensitivity testing with one test card lot, which may result in false negative results.

    Product
    InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemica
    Category
    Medical Device
    Distribution
    Distributed nationwide